Ignite Creation Date:
2025-12-24 @ 3:18 PM
Ignite Modification Date:
2025-12-29 @ 7:03 PM
Study NCT ID:
NCT00820092
Status:
COMPLETED
Last Update Posted:
2013-07-30
First Post:
2008-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Xerecept Intravenous Dose Escalation in Japanese and Caucasian Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004487', 'term': 'Edema'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-29', 'studyFirstSubmitDate': '2008-12-14', 'studyFirstSubmitQcDate': '2009-01-07', 'lastUpdatePostDateStruct': {'date': '2013-07-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency and severity of AEs Clinical laboratory tests( chemistry,hematology,urinalysis) Physical exam and vital signs ECG AUC, Tmax Cmax Terminal half life AUC for cortisol concentration', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Xerecept', 'Pharmacokinetics', 'Japanese versus Caucasians'], 'conditions': ['Edema']}, 'descriptionModule': {'briefSummary': '1. To investigate the safety and tolerability of Xerecept during and following a 24-hour intravenous administration to healthy Japanese to healthy Japanese and Caucasian subjects\n2. To compare the PK profile of hCRF during and following a 24-hour intravenous Xerecept administration between healthy Japanese and Caucasian subjects', 'detailedDescription': 'none needed'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and female Japanese subjects who are citizens of Japan\n* Healthy male and female Caucasian subjects\n* Age range 20-45 years\n* BMI \\>19 and \\<27 kg/m squared\n\nExclusion Criteria:\n\n* Female subjects must not be pregnant at the time of study and use adequate birth control methods before,during and 4 weeks after the study\n* Subjects must be negative for HCV and HIV\n* Subjects must have negative urine tests for drugs of abuse and alcohol at screening\n* Subjects must not have any clinically significant medical conditions'}, 'identificationModule': {'nctId': 'NCT00820092', 'briefTitle': 'Xerecept Intravenous Dose Escalation in Japanese and Caucasian Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celtic Pharma Development Services'}, 'officialTitle': 'A Phase 1,Dose Escalation Study to Compare the Safety, Tolerability,Pharmacokinetic and Pharmacodynamic Profiles of the 24-hour Intravenous Administration of Xerecept in Healthy Japanese and Caucasian Adult Volunteers', 'orgStudyIdInfo': {'id': 'Xerecept: CPDS 0805'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Xerecept 1.0', 'description': '1.0 ug/kg/hr hCRF -24 hour IV infusion', 'interventionNames': ['Drug: Xerecept 1.0']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Xerecept 2.0', 'description': '2.0 ug/kg/hr-24 hour IV infusion', 'interventionNames': ['Drug: Xerecept 2.0']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Xerecept 3.0', 'description': '3.0 ug/kg/hr-24 hour infusion', 'interventionNames': ['Drug: Xerecept 3.0']}], 'interventions': [{'name': 'Xerecept 1.0', 'type': 'DRUG', 'otherNames': ['hCRF infusion', '1.0 ug/kg/hr'], 'description': '24 hour infusion', 'armGroupLabels': ['Xerecept 1.0']}, {'name': 'Xerecept 2.0', 'type': 'DRUG', 'otherNames': ['hCRF infusion', '2.0 ug/kg/hr'], 'description': '24 hour infusion', 'armGroupLabels': ['Xerecept 2.0']}, {'name': 'Xerecept 3.0', 'type': 'DRUG', 'otherNames': ['hCRF infusion', '3.0 ug/kg/hr'], 'description': '24 hour infusion', 'armGroupLabels': ['Xerecept 3.0']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90630', 'city': 'Cypress', 'state': 'California', 'country': 'United States', 'facility': 'West Coast Clinical Trials', 'geoPoint': {'lat': 33.81696, 'lon': -118.03729}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Celtic Pharma Development Services', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}